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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: 2-butyl-9-methyl-8-(2H-1,2,3-triazol-2-yl)-9H-purin-6-amine A triazole purine analogue
Date Designated: 06/08/2022
Orphan Designation: Treatment of Non-24 Sleep Wake Rhythm Disorder (N24SWRD) in blind individuals without light perception
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Circadian Therapeutics Ltd.
Oxford Centre for Innovation
New Road
Oxford OX1 1BY
United Kingdom

The sponsor address listed is the last reported by the sponsor to OOPD.
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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